Evidence map›Paper›PMID 36730323›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

Phase I Study of the Liposomal Formulation of Eribulin (E7389-LF): Results from the Advanced Gastric Cancer Expansion Cohort.

Kohei Shitara, Motohiro Hirao, Satoru Iwasa, Takashi Oshima, Yoshito Komatsu, Akihito Kawazoe, Yasuyoshi Sato, Takuya Hamakawa, Kan Yonemori, Nozomu Machida and 8 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  2. Article
  3. Article
  4. Article
  5. Nanodrugs Targeting T Cells in Tumor Therapy.Frontiers in immunology · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 2 countries.

Kohei ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Canter Hospital East, Kashiwa, Japan.ORCID 0000-0001-5196-3630
Motohiro HiraoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.ORCID 0000-0002-6509-6416
Satoru IwasaDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-3863-9582
Takashi OshimaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.ORCID 0000-0001-5818-8649
Yoshito KomatsuDepartment of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Hokkaido, Japan.ORCID 0000-0002-1570-6802
Akihito KawazoeDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Canter Hospital East, Kashiwa, Japan.ORCID 0000-0001-8632-3748
Yasuyoshi SatoDepartment of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0003-4145-8694
Takuya HamakawaDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.ORCID 0000-0002-2329-4289
Kan YonemoriDepartment of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-7624-7611
Nozomu MachidaDepartment of Gastroenterology and Medical Oncology, Kanagawa Cancer Center, Kanagawa, Japan.ORCID 0000-0001-9570-3670
Satoshi YukiDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.ORCID 0000-0002-2039-3062
Takuya SuzukiJapan and Asia Clinical Development Department, Oncology Business Group, Eisai Co., Ltd., Tokyo, Japan.ORCID 0000-0001-7692-9447
Shiori OkumuraJapan and Asia Clinical Development Department, Oncology Business Group, Eisai Co., Ltd., Tokyo, Japan.ORCID 0000-0002-3277-3513
Takao TakaseClinical Data Science Department, Medicine Development Center, Eisai Co., Ltd., Tokyo, Japan.ORCID 0000-0002-4556-5035
Taro SembaTsukuba Research Department, Oncology Business Group, Eisai Co., Ltd., Ibaraki, Japan.ORCID 0000-0003-0432-1138
Bob ZimmermannTranslational Science, Oncology Business Group, Eisai Inc., Nutley, New Jersey.ORCID 0000-0003-2354-0408
Angela TengBiostats, Oncology Business Group, Eisai Inc., Nutley, New Jersey.ORCID 0000-0002-7626-2141
Kensei YamaguchiDepartment of Gastroenterological Chemotherapy, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0001-6887-5709
Eisai (Japan) · JPHokkaido University Hospital · JPJapanese Foundation For Cancer Research · JPKanagawa Prefectural Hospital Organization · JPNational Cancer Center Hospital East · JPNational Cancer Centre Japan · JPOsaka National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the dose-expansion part of this open-label, phase I study, we explored the efficacy and safety of E7389-LF (liposomal formulation of eribulin) in Japanese patients with advanced gastric cancer. PATIENTS AND

methodsPatients with advanced gastric cancer who had been previously treated with ≥2 lines of chemotherapy received E7389-LF 2.0 mg/m2 every 3 weeks (the previously determined maximum tolerated dose, the primary objective of Study 114). Secondary objectives included objective response rate (ORR), progression-free survival (PFS), and safety; exploratory objectives included disease control rate (DCR) and clinical benefit rate (CBR), as well as pharmacodynamic measurements of serum biomarkers.

resultsAs of June 24, 2021, 34 patients were enrolled and treated (10 from the original dose-expansion cohort, expanded to include 24 additional patients). Six patients had partial responses, for an ORR of 17.6% [95% confidence interval (CI), 6.8-34.5], and the median PFS was 3.7 months (95% CI, 2.7-4.8). The DCR was 79.4% (95% CI, 62.1-91.3), and the CBR was 32.4% (95% CI, 17.4-50.5). Overall, 32 patients (94.1%) experienced treatment-related adverse events, and 26 patients (76.5%) experienced grade ≥3 events, most commonly neutropenia (41.2%) and leukopenia (29.4%). Of the 8 endothelial cell/vasculature markers tested in this study, 7 were significantly increased among patients treated with E7389-LF; these changes were generally consistent regardless of best overall response.

conclusionsE7389-LF 2.0 mg/m2 every 3 weeks was tolerable and showed preliminary activity for the treatment of patients with gastric cancer.

Indexed as

Stomach NeoplasmsFuransHumansKetonesPolyether PolyketidesProgression-Free SurvivaleribulinFuransKetonesPolyether Polyketides

Identifiers

PMID36730323
PMCPMC10102841
OpenAlexW4318932570

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.